Plant Protection Products and

Fertilizers trials for state registration in

the Republic of Belarus

Belarus, 2009 год

Aliaksei MAISEYENKA - deputy director of State enterprise

«The Main State Inspection on seed-breeding, quarantine and

plant protection», Republic of Belarus

Tamara Golobob - chief of the department of registration of

chemical and biological plant protection means and fertilizers

of State enterprise «The Main State Inspection on seed-

breeding, quarantine and plant protection», Republic of

Belarus

Volha Klachkova - scientist laboratory of preventive and

ecological toxicology of State Enterprise «Republican

scientifically practical center of hygiene»

Total: 606 plant protection products and 256 active ingredients

ГОСУДАРСТВЕННЫЙ РЕЕСТР

СРЕДСТВ ЗАЩИТЫ РАСТЕНИЙ

(ПЕСТИЦИДОВ) И УДОБРЕНИЙ,

РАЗРЕШЕННЫХ К ПРИМЕНЕНИЮ НА

ТЕРРИТОРИИ РЕСПУБЛИКИ

БЕЛАРУСЬ

The obligatory condition for state registration of pesticides andfertilizers is their trials, which include state hygienic regulation,assessment of biological and economic efficacy and developmentof their application regulations.

Trials for plant protection products and fertilizers for evaluation of

biological and economical efficiency are performed by legal

institutions that passed assessment in accordance with “Instruction

on order of carrying out trials of plant protection means and

fertilizers, which are subjected to state registration” and

“Instruction on order of carrying out certification of legal

institutions conducting trials of plant protection means and

fertilizers, which are subjected to the state registration”.

The certification is carried out by the Ministry of Agriculture

and Food of the Republic of Belarus .

Biological and economical efficiency trials of Plant Protection

Products, with new or registered earlier active ingredients and

their combinations, must be carried out during two-seasons for

each crop.

One season trial is necessary to extend the registration for a new

crop.

Biological and economical efficiency trials can be prolonged for

one more vegetation season in case of unusual conditions.

Residues of Plant Protection Products in plant production are

determined during biological and economical efficiency trials

of Plant Protection Products.

The rules of Plant Protection Products and Fertilizers use for

including into the “State Catalogue of Plant Protection Products

(Pesticides) and Fertilizers allowed for usage in the Republic of

Belarus” are discussed by experts for evaluation of biological

efficiency of herbicides, insecticides, fungicides and seed

treatment products, biological products, pheromones, growth

regulators and fertilizers during their workgroups meetings.

The Ministry of Agriculture and Food

The members of expert workgroups

The Ministry of Forestry

The State Enterprise “The Main State Inspection for

Seed-Growing, Quarantine and Plant Protection”

The National Academy of Sciences of Belarus

Information on legislation about

plant protection of the Republic

of Belarus can be obtained on the

sites: www.pravo.by, ggiskzr.by.

The basic technical normative legal

certificates (acts)

• SR № 2.2.3.12-17-2003 “Hygienic

requirements to storage, application and

transportation of pesticides and

agrochemicals”

• The instruction № 2.2.3.10-24-81-2006

“Requirements to carry out state sanitary-

and-hygienic expertize of plant protection

means”

Functions of State Institution «Republican scientific - practical center

of hygiene» Ministry of Health of Republic of Belarus on pesticides

safe handling on the territory of Republic of Belarus

• Full toxico-hygienic expertizeof pesticides data for their hygienic registration in BY;

• Adaptation of methods for pesticides active ingredients determination in environment and

agricultural production (the purposes are:

• to implement state sanitary inspection of manufacture and application of pesticides,

• to check pesticides residue content in food stuffs,

• to reveal possible contamination sources of environment,

• to monitor inhabitant surroundings);

• Development of pesticides hygienic specifications (provides their safe use, an opportunity to

control their contents in environment);

• Development of recommendations for pesticides safe application;

• Investigation of labourconditions during pesticides application to estimate risk of adverse

influence on workers;

• Toxicological investigation of new synthesized pesticides f ormulations and their active

ingredients.

Toxico-hygienic expertise of pesticides

• Themanufacturerof apesticideand activeingredient

• Tradename

• Function

• Activeingredient.Chemicalclass.Concentration(ing/lorg/kg).Formulation

• Sphereofapplication(onwhatcropsitissupposed).

• Recommended rate and way of application. Recommended rules of application. Recommended pre-

harvest period.

• Physical and chemical properties of active ingredient (structural formula, the empirical formula,

molecularmass,aggregatestate, solubility inwater, solubility inorganicsolvents,color,odor,etc.).Purity

of atechnicalproduct,qualitativeandquantitativecomposition ofimpurity.

• Physicalandchemicalpropertiesof formulation (aggregate state,color, odor, ahydrogenindex,water

content(%),qualitativeandquantitativecompositionofimpurity,storagestability).

• Physicalandchemicalcharacteristics,percentageandfunctionofconstituents informulation.

• The toxicological characteristic of active ingredient:

• Acute oral toxicity, a threshold of acute action. Acute dermal toxicity acute

inhalation toxicity. A threshold of acute action. Clinical signs of acute intoxication

• Skin and mucous membranes irritation

• Delayed neurotoxiceffect in hens (it is necessary for phosphorus-organic pesticides,

for others - if necessary);

• Subacuteoral toxicity (cumulative properties), cumulative coefficient.

• Subacute epidermal toxicity

• Sensitization, immunotoxicity

• Chronic toxicity (NOEL, NOAEL)

• Carcinogenicity determined by administering a test agent to two types of animals

(mice and rats) for two years.

• Teratogenicity and embriotoxocity, using methods allowing to reveal embryo/fetal

anomalies or any signs of toxicity.

• Reproductive toxicity using 2-generations studies and gonadotoxicity

• Mutagenicity: (not less than three tests, including Ames test and mammal test in vivo)

• Metabolism in mammals, major metabolites

• Limiting factor of adverse effect allowable daily intake (ADI) mg/rgof human body weight

• Metabolism in environmental objects including agricultural plants.

• Toxicology of a Formulation and its constituents

• Product Composition (Chemical names of each constituent of a product, function of constituents

in a formulation)

• Acute oral toxicity , acute dermal toxicity, acute inhalation toxicity;

• Skin and mucous membranes irritation

• Subacuteoral toxicity (cumulative properties), cumulative coefficient. Subacuteepidermal toxicity

Subacute in halation toxicity

• Sensitization;

• Toxicology of the formulation ingredients (fillers, emulsifiers, stabilizers, solvents).

• Hygienic Characteristics of a Formulation: Effect on the quality and nutritional value of crops

• Recommended hygienic normatives of residual quantities of pesticides in foodstuff

and environment, waiting periods (for persistent formulations capable to translocate

into plants and migrations in adjacent environments maximum allowed concentration

for soil is submitted, for other formulations -approximate allowable concentration in

soil is submitted).

• Recommendations on diagnosis and treatment in case of acute poisoning including first

aid measures in poisoning, antidotes

• Residues data and data on waiting periods for each crop

• Hygienic analysis of labour conditions during product application taking into account

maximal dose rates, number of treatments and various technologies in conditions of

Republic of Belarus/ Proposals supported by appropriate data on re-entry periods

• Speed of decomposition of active ingredients (Т50 and Т90) in soil and water;

• The name of toxic metabolites if those are available;

• Methods of residue analyses in environment and food

Experimental toxico-hygienic researches

• For active ingredient and formulation of foreign pesticide:

determination of danger class on base of acute oral toxicity and dermal toxicity on

laboratory animals with estimation of a clinical picture of toxic action and

establishment of LD50, LD50cut and comparative characteristic of a clinical picture of

acute intoxication and parameters of acute toxicity with the original data ( in dossier of

the firm).

• For locally produced pesticide (formulation is produced on the territory of Belarus

using foreign active ingredients): laboratory experiment on acute toxicity of

formulation (oral, dermal, inhalation) using laboratory animals with estimation of

clinical picture of toxic action, establishment parameters of acute toxicity and a class of

danger; studying irritating influence on eyes; researches on subacute toxicity of

formulation in two-months experiment on skin and mucous membranes of laboratory

animals; an estimation of sensibilizing effect of formulation.

For locally produced pesticides

(formulation and active ingredient are

produced on the territory of Belarus)

• Laboratory experiments on acute toxicity of formulation and active ingredient (oral, dermal,

inhalation) on laboratory animals with estimation of a clinical picture of toxic effect and an

establishment of parameters of acute toxicity and a class of danger;

• Studying irritating effect of formulation and active ingredient on skin and mucous membranes of

eyes of laboratory animals;

• Studying subacute toxicity of formulation and active ingredient in two-months experiments on

laboratory animals;

• An estimation of sensibilizingeffect of formulation and active ingredient of pesticide;

• Studying chronic toxicity, the remote effects (embryo-and gonadotoxiceffect, reproductive

toxicity, mutagenic and cancerogenicproperties)of active ingredient with an establishment of

maximum invalid dozes, calculation of an allowable daily doze and a substantiation of hygienic

specifications.

For all categories of pesticides conduct

• A hygienic estimation of labour conditions with calculation of all owable risk at

application of a pesticide taking into account maximal rates, applications number

andvarioustechnologies in conditionsof Belarus,asubstantiationof terms of a safe

re-entryperiods

• Studying labour conditions for pesticides used in green houses is carried out

irrespective of labour conditions resultsavailability inconditionsofanopenair .

• Labour condition trials are conducted for private and state firms separately in each

case;

• Residue determination of pesticide in agricultural products.

• Activeingredient amountdetermination in formulation

• Aprobation and adaptation methods of active ingredient residue amount

determination inenvironment and agricultural products.

Supervision of plant protection means

application in agriculture is carried out

• At storage and delivery of pesticides and agrochemicals

• At work with machines and equipment

• At application of pesticides and agrochemicals using ground equipment

• At application of pesticides and agrochemicals using aviation equipment

• At application of pesticides and agrochemicals in green houses

• At seed treatment, their storage, transportation and sowing

• At application of pesticides and agrochemicals in private farms

• At use of individual protection means by workers contacting with pesticides and agrochemicals

• At disinfection of transport means, equipments, containers, premises and overalls

• At performance of environment protection actions and maintenance of release of qualitative

food production

• At transportation of pesticides and agrochemicals.

Main principles of the state sanitary-

and-hygienic expertize

• It is compulsory

• Its conclusions are scientifically based;

• Independence of experts;

• It’s complete

• It’s confidential